MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ELECTROSURGICAL UNIT

Model Number	UES-40
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested regarding this event; however, it has not been received.The device was not returned to olympus for evaluation.A supplemental report will be submitted if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that the output/input ports on the evis exera ii bronchovideoscope were burned.There were no reports of patient harm associated with this event.
Event or Problem Description
The customer reported to olympus that the electrosurgical unit output / input connection seems to be burned, however, the device is still working as normal.The issue was observed during preparation for use on a therapeutic (hystroscopy) procedure.The procedure was completed with a similar device and a 15-minute delay.There were no reports of patient or user harm associated with this event.
Additional Manufacturer Narrative
The device was returned to olympus for a device evaluation and the customer¿s allegation was confirmed.A full technical evaluation was completed in accordance with the original equipment manufacturer¿s specification and the results showed that there were burn traces on the front panel.However, the device did work correctly, and no damages were found inside.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Additional Manufacturer Narrative
This supplemental report is to correct the initial mdr.The initial medwatch reported that during a hysteroscopy procedure, the output/input on the device seemed to be burned however was still working as normal but led to a 15-minute procedural delay.Another device was used to complete the procedure.The issue did not have any effects on the patient or other healthcare worker.Although a procedural delay was reported, the customer confirmed that there were no adverse effects to the patient and the procedure was completed.The procedural delay is not considered life-threatening, nor did it lead to a permanent impairment in the patient.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: ELECTROSURGICAL UNIT
• Common Device Name: ELECTROSURGICAL UNIT
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17414561
• Report Number: 3002808148-2023-07654
• Device Sequence Number: 8976165
• Product Code: GEI
• UDI-Device Identifier: 04953170165429
• UDI-Public: 04953170165429
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K030194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: UES-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 07/31/2023; 09/27/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 08/22/2023; 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2005
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown